FDA Device recall Z-2521-2018
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 by Depuy Orthopaedics, citing two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2521-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Depuy Orthopaedics |
| Distribution | AL, CA, CO, GA, IL, LA, ME, NC, NH, NY, OR, TX, UT, WA |
Product
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Reason
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Identifiers
| code_info | 5307603 5300997 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2521-2018%22
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